COVID-19NCT05321004
Barriers and Facilitators of Key Stakeholders to Implement Remote Monitoring Technologies: a Mixed-methods Analysis
An observational study of COVID-19, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Advancements in digital technologies alongside the global pandemic of COVID-19 have accelerated the adoption of novel healthcare pathways worldwide, with healthcare delivery transitioning beyond the traditional face-to-face model. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Previous experience in implementing remote monitoring solutions
Who may be able to join
- A mixed methods approach will be implemented: semi-structured interviews will be conducted with high level stake holders from industry, academia, and healthcare providers who have played an instrumental role with prior experience of implementing digital solutions.
Who cannot join
- not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barriers and Facilitators of Key Stakeholders in Implementing Remote Monitoring Technologies: a Mixed-methods Analysis
Advancements in digital technologies alongside the global pandemic of COVID-19 have accelerated the adoption of novel healthcare pathways worldwide, with healthcare delivery transitioning beyond the traditional face-to-face model. Telemedicine has gained long over- due exposure during a complicated crisis; as the number of cases continue to grow with second waves predicted, digital modalities have become critical in moderating exposure risk to healthcare staff, reducing community spread, and delivering quality healthcare remotely for exposed or infected individuals.
Remote monitoring solutions are being established internationally to allow individuals to continue living at home rather than in expensive hospital facilities using non-invasive digital technologies (such as wearable sensors) to collect health data, support health provider assessment and clinical decision making.
Read more
With the advances in technology miniaturisation, sensors have become increasingly portable, unobtrusive, lightweight, and waterproof, offering an emerging solution to continuous remote monitoring of vital signs. It is predicated that continuous monitoring allows for early recognition of clinical deterioration, and through digital alerting, offers an opportunity for earlier clinical intervention, improving patient care and patient outcomes.
Within the United Kingdom (UK), widespread digital transformations are facilitated by NHS digital, a non-departmental public body created by statute, delivering large health informatics programmes. As such, this study aims to investigate key stakeholder perspectives on an organisational level of implementing remote monitoring solutions, given the pandemic, in the National Health Service (NHS), identifying factors that could affect successful execution and adoption.
- Conditions
- COVID-19
- Being tested
- Semi-structured interviews will be conducted - there will be no intervention.
- Keywords
- implementation science
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviews will be conducted - there will be no intervention.Other
The use of semi structured interviews and questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated TAM (technology acceptance model) questionnaire
Liberty scale questionnaire responses
Measured: 1 year
Thematic analysis
Semi structured interviews using a predetermined topic guide on questions relating to barriers and facilitators
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321004
- Sponsor's protocol ID
- 20IC6331
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iqbal FM, Aggarwal R, Joshi M, King D, Martin G, Khan S, Wright M, Ashrafian H, Darzi A. Barriers to and Facilitators of Key Stakeholders Influencing Successful Digital Implementation of Remote Monitoring Solutions: Mixed Methods Analysis. JMIR Hum Factors. 2024 May 6;11:e49769. doi: 10.2196/49769.
PubMed 37338929Iqbal FM, Joshi M, Khan S, Wright M, Ashrafian H, Darzi A. Key Stakeholder Barriers and Facilitators to Implementing Remote Monitoring Technologies: Protocol for a Mixed Methods Analysis. JMIR Res Protoc. 2022 Jul 21;11(7):e38437. doi: 10.2196/38437.
PubMed 35862185
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators of Key Stakeholders in Implementing Remote Monitoring Technologies: a Mixed-methods Analysis
- ClinicalTrials.gov ID
- NCT05321004
- Acronym / sponsor ID
- 20IC6331
- Conditions
- COVID-19
- Keywords
- implementation science
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advancements in digital technologies alongside the global pandemic of COVID-19 have accelerated the adoption of novel healthcare pathways worldwide, with healthcare delivery transitioning beyond the traditional face-to-face model. Telemedicine has gained long over- due exposure during a complicated crisis; as the number of cases continue to grow with second waves predicted, digital modalities have become critical in moderating exposure risk to healthcare staff, reducing community spread, and delivering quality healthcare remotely for exposed or infected individuals.
Remote monitoring solutions are being established internationally to allow individuals to continue living at home rather than in expensive hospital facilities using non-invasive digital technologies (such as wearable sensors) to collect health data, support health provider assessment and clinical decision making.
With the advances in technology miniaturisation, sensors have become increasingly portable, unobtrusive, lightweight, and waterproof, offering an emerging solution to continuous remote monitoring of vital signs. It is predicated that continuous monitoring allows for early recognition of clinical deterioration, and through digital alerting, offers an opportunity for earlier clinical intervention, improving patient care and patient outcomes.
Within the United Kingdom (UK), widespread digital transformations are facilitated by NHS digital, a non-departmental public body created by statute, delivering large health informatics programmes. As such, this study aims to investigate key stakeholder perspectives on an organisational level of implementing remote monitoring solutions, given the pandemic, in the National Health Service (NHS), identifying factors that could affect successful execution and adoption.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Previous experience in implementing remote monitoring solutions
Key inclusion criteria (1 listed)
- A mixed methods approach will be implemented: semi-structured interviews will be conducted with high level stake holders from industry, academia, and healthcare providers who have played an instrumental role with prior experience of implementing digital solutions.
Key exclusion criteria (1 listed)
- not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviews will be conducted - there will be no intervention.The use of semi structured interviews and questionnaires | Other | – |
Primary outcome
Validated TAM (technology acceptance model) questionnaire
Time frame: 1 year
Liberty scale questionnaire responses
Thematic analysis
Time frame: 1 year
Semi structured interviews using a predetermined topic guide on questions relating to barriers and facilitators
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 37338929Iqbal FM, Aggarwal R, Joshi M, King D, Martin G, Khan S, Wright M, Ashrafian H, Darzi A. Barriers to and Facilitators of Key Stakeholders Influencing Successful Digital Implementation of Remote Monitoring Solutions: Mixed Methods Analysis. JMIR Hum Factors. 2024 May 6;11:e49769. doi: 10.2196/49769.
- Derived from this study: PubMed 35862185Iqbal FM, Joshi M, Khan S, Wright M, Ashrafian H, Darzi A. Key Stakeholder Barriers and Facilitators to Implementing Remote Monitoring Technologies: Protocol for a Mixed Methods Analysis. JMIR Res Protoc. 2022 Jul 21;11(7):e38437. doi: 10.2196/38437.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated TAM (technology acceptance model) questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321004, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.